First-in-Human (FIH) Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas

• Status: Recruiting
• Trial end date: 2023-05-30
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this first-in-human trial is to characterize the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic characteristics of GEN3009 (DuoHexabody®-CD37) in subjects with relapsed/refractory B-cell Non-Hodgkin Lymphoma (NHL).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genmab
• Collaborator: AbbVie

Criteria

Inclusion Criteria:

1. Be at least 18 years of age.

2. Must sign an informed consent form prior to any screening procedures.

3. Has histologically or cytologically confirmed relapsed and/or refractory B-cell NHL with no available standard therapy or is not a candidate for available standard therapy, and for whom, in the opinion of the investigator, experimental therapy with GEN3009 may be beneficial. All subjects must have received at least two prior lines of systemic therapy.

4. Has one of the specified subtypes for B-cell NHL for the Dose Escalation and Dose Expansion parts of the study.

5. Has measurable disease for B-cell NHL or has active disease for Chronic Lymphocytic Leukemia (CLL).

6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

7. Has adequate hepatic, renal, and bone marrow functions.

8. Before the first dose of GEN3009, during the trial, and for 12 months after the last dose of GEN3009, a woman must be either not of childbearing potential or of childbearing potential and practicing a highly effective method of birth control, and must have a negative serum beta-human chorionic gonadotropin (beta-hCG) and urine pregnancy test at screening.

9. A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control.

Exclusion Criteria:

1. Prior treatment with a CD37-targeting agent.

2. Prior allogeneic Hematopoietic Stem Cell Transplantation (HSCT).

3. Autologous HSCT within 3 months before the first dose of GEN3009.

4. Treatment with an anti-cancer biologic including anti-CD20 therapy, radio-conjugated or toxin-conjugated antibody or chimeric antigen receptor (CAR) T-cell therapy within 4 weeks or 5 half-lives, whichever is shorter, before the first dose of GEN3009.

5. Chemotherapy or radiation therapy within 2 weeks of the first dose of GEN3009.

6. Treatment with an investigational drug or an invasive investigational medical device within 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of GEN3009.

7. Autoimmune disease or other diseases that require permanent or high-dose immunosuppressive therapy.

8. Received a cumulative dose of corticosteroids more than the equivalent of 250 mg of prednisone within the 2-week period before the first dose of GEN3009.

9. Has uncontrolled intercurrent illness.

10. Toxicities from previous anti-cancer therapies have not resolved to baseline levels or to Grade 1 or less except for alopecia and peripheral neuropathy.

11. Primary central nervous system (CNS) lymphoma or known CNS involvement at screening.

12. Known past or current malignancy other than inclusion diagnosis,

13. Has had major surgery within 3 weeks before screening or will not have fully recovered from surgery, or has major surgery planned during the time the subject is expected to participate in the trial (or within 4 weeks after the last dose of GEN3009).

14. Known history/positive serology for hepatitis B.

15. Known medical history or ongoing hepatitis C infection that has not been cured.

16. HIV tested positive at screening.

17. Is a woman who is pregnant or breast-feeding, or who is planning to become pregnant while enrolled in this trial or within 12 months after the last dose of GEN3009.

18. Is a man who plans to father a child while enrolled in this trial or within 12 months after the last dose of GEN3009.